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NCT02414919 Clinical Trial

Duration of Use of Highly Effective Reversible Contraception

Pregnancy Clinical Trial

Official title:
Real-world Duration of Use for Highly Effective Reversible Contraception (HERC): A Retrospective Review

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02414919
Other study ID # 17714
Secondary ID
Status Completed
Phase N/A
First received April 8, 2015
Last updated March 14, 2017
Start date April 1, 2015
Est. completion date March 28, 2016

Study information
Verified date March 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the proportion of women who use HERC for ≥2 years of duration

Recruitment information / eligibility
Status Completed
Enrollment 13880
Est. completion date March 28, 2016
Est. primary completion date March 28, 2016
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 44 Years
Eligibility Inclusion Criteria:

-Women who had an IUD or contraceptive implant inserted and removed within the University of Utah from January 1, 2004 to October 31, 2012

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mirena (Levonorgestrel IUS, BAY86-5028)
Levonorgestrel-releasing intrauterine device 20 mcg/day
• ParaGard
Copper T380A
• Implanon/Nexplanon
Etonorgestrel contraceptive implant

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bayer University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (3)

Sanders J, Turok D, Gawron L, Law A, Wen L, Lynen R. Continuation of Long-Acting Reversible Contraception at Two Years in a University Healthcare Setting: A Retrospective Review. JMCP 2016;22(4a):S126

Sanders J, Turok D, Gawron L, Law A, Wen L, Lynen R. Three-Year Continuation of Long-Acting Reversible Contraceptive methods in a Mixed-Payer Health Care Setting: A Retrospective Review. Contraception 2016;94:405-406.

Sanders JN, Turok DK, Gawron LM, Law A, Wen L, Lynen R. Two-year continuation of intrauterine devices and contraceptive implants in a mixed-payer setting: A retrospective review. Am J Obstet Gynecol. 2017 Feb 8. pii: S0002-9378(17)30180-1. doi: 10.1016/j. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Difference in patient characteristics of women who chose different HERC devices 2 years post-HERC initiation
Other Proportion of HERC used for =3 years of duration =3 years post-HERC initiation
Other Model the predictors of =3 years of duration =3 years post-HERC initiation
Primary Proportion of women who use HERC 2 years post-HERC initiation
Secondary Duration of real world use of three different HERC devices 2 years post-HERC initiation
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